Risankizumab in Japanese patients with moderate-to-severe palmoplantar pustulosis: Results from the randomized, phase 3 JumPPP study.

Palmoplantar pustulosis (PPP) is a chronic, debilitating skin disease of the palms and/or soles. We report the efficacy and safety of risankizumab (RZB), an interleukin 23 p19 inhibitor, from the JumPPP study (a phase 3, multicenter, randomized, placebo-controlled, double-blind study to evaluate RZB in adult Japanese sUbjects with Moderate-to-severe PalmoPlantar Pustulosis; NCT04451720). Patients were randomized 1:1 to receive RZB (150 mg) or placebo at weeks 0 and 4; all patients received RZB from week 16 to week 52 (patients initially randomized to RZB) or week 56 (patients initially randomized to placebo). The primary end point was a Palmoplantar Pustulosis Area and Severity Index (PPPASI) change from baseline; secondary end points were ≥50%/≥75% improvement in PPPASI (PPPASI 50/75) at week 16. Efficacy and safety were evaluated to 68 and 76 weeks, respectively. In total, 119 patients (RZB, n = 61; placebo, n = 58) were enrolled. Greater improvement with RZB versus placebo was demonstrated by the significant difference in PPPASI change from baseline at week 16 (least squares mean treatment difference, -3.48; p < 0.05). At week 16, a greater proportion of patients receiving RZB vs placebo achieved PPPASI 50 (41.0% vs 24.1%; nominal p < 0.05) but not PPPASI 75 (13.1% vs 15.5%; nominal p = 0.74). Improvements generally continued through to week 68. The safety profile was generally consistent with previous studies of RZB in psoriasis. RZB demonstrated efficacy over placebo at week 16 in Japanese patients with PPP, with improvements sustained through to week 68, and was well tolerated with no unexpected safety findings.